Sleeve gastrectomy surgery is one of the most frequently performed procedures for the treatment of morbid obesity with estimates that more than 200,000 gastrectomy procedures may be performed in the United States in the next year. In a gastrectomy procedure, the volume of the stomach into which food may pass and be processed is reduced. This reduction is commonly achieved by removing a large portion (commonly 75%) of the stomach and stapling the remaining portion of the stomach shut, providing a smaller residual food-processing portion of the stomach called the stomach sleeve.
With existing gastrectomy technology, operating room personnel use multiple separate tubes to pass through a patient's mouth and esophagus into the patient's stomach in order to perform gastric procedures. The procedure can involve (i) first inserting a standard tube, such as a nasogastric tube, having only a suction channel to inflate the stomach, evacuate the gastric contents from the patient's stomach, and deflate the stomach, (ii) removing the suction tube and inserting a separate, solid sizing calibration rod or bougie into the stomach to guide the cutting/stapling of the stomach adjacent the rod, to yield the residual stomach sleeve of reduced volume, and (iii) removal of the calibration rod insertion of a standard nasogastric tube into the stomach, to deflate the stomach perform a leak test by inserting colored dye into, and distending, the residual stomach. The multiple tube procedure is not only time consuming but also increases the risk of lengthier anesthesia, trauma to the patient during the procedure, and a resulting residual stomach sleeve that is unnaturally shaped and/or too narrow, and thus subject to risk of becoming twisted, called the “windsock deformity,” or otherwise becoming blocked.
For example, one particularly serious type of gastrectomy patient trauma, esophageal perforation, is believed to occur in less than 0.03% of gastrectomy tube insertions. This type of trauma is, however, a gravely serious complication, resulting in mortality in over 20% of cases in which perforation occurs.
As another example, the windsock deformity occurs in approximately 1% of gastrectomy procedures, and post-operative stenosis or narrowing of the resulting stomach sleeve occurs in between 1% and 3% of cases of sleeve gastrectomy. Given that there hundreds of thousands of such procedures every year in the U.S., these complications present real and costly problems.
Existing sleeve tubes are typically straight and include, for example, the ViSiGi 3D tube from Boheringer Ingelheim (e.g., having a French (“Fr”) gauge (or width) of 36 or 40). Straight sleeve tubes promote a straightening of the stomach, which can yield a less naturally shaped and unduly narrow stomach sleeve that is more prone to twisting, kinking, and obstructing.
The ViSiGi 3D tube also has only single channel that can become clogged prematurely by gastric contents during the gastrectomy procedure. When this occurs, the tube must be removed, cleared, and re-inserted into the patient to complete removal of gastric contents and deflation of the stomach.
Nasogastric Sump tube model number 0042140 from Bard Medical has two channels: a suction channel and a sump channel in material transfer communication with apertures in the working end section. Like most prior art gastrectomy tubes, this Bard Medical tube has a working end section that is straight, too narrow (from 10-18 Fr.) to provide a guide to help the physician calibrate the size of the residual stomach sleeve, and a blunt, relatively inflexible tip, which also can result in anatomical trauma to the patient during the gastrectomy procedure.
Consequently, existing tube technology typically fails to suction, aspirate, and deflate the stomach adequately, quickly, and with reduced risk of trauma to the patient during the procedure and afterwards, such as due to the windsock deformity and/or other complications due to an unnatural and/or excessively narrow shape of the residual stomach sleeve.